CompletedNot Applicable

Control Trial of Intermittent Hemodialysis With Regional Citrate VS Priming Heparin With Predilution in Patients at Risk of Bleeding

France60 participantsStarted 2019-03-11

Plain-language summary

The study investigators hypothesize that intermittent hemodialysis with regional citrate anticoagulation (Prometheus system/Frésénius) is more efficient than reduced systemic heparin anticoagulation in patients at bleeding risk hospitalized in nephrology intensive care unit

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * The patient has been correctly informed. * The patient must have given his/her informed and signed consent. * The legal guardian or trusted-person of an adult under guardianship must have given their informed and signed consent. * The patient has health insurance coverage via the French social security system. * The patient is at least 18 years old. * The patient is at bleeding risk; the bleeding risk is defined by the clinical situation and according to predefined clinical situations (before or after surgery or biopsy, hemorrhage). * The patient requires an intermittent hemodialysis in a nephrology ICU setting. Exclusion Criteria: * The patient is participating in, or has participated in over the past three months, another interventional trial. * The patient is in an exclusion period determined by a previous study. * The patient is under judicial protection. * The parents (or legal guardian) of the patient refuse to sign the consent. * It is impossible to correctly inform the patient/parents (or legal guardian) of the patient (language barrier). * Contraindication to heparin treatment. * Indication of continuous dialysis in ICU. * Pregnancy.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Duration of intermittent hemodialysis between groups

Timeframe: End of intermittent hemodialysis session (average 4 hours)

Trial details

NCT IDNCT03562754

SponsorCentre Hospitalier Universitaire de Nīmes

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05-27

View on ClinicalTrials.gov More Hemodialysis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.